FULL TIME
Killorglin, Kerry
Réalta Technologies are searching for a CSV Engineer with 5+ years experience to support our client's advanced pharmaceutical Fill/Finish facility in Killorglin, Co.
Kerry.
The successful candidate will ensure that all computerized systems meet regulatory, quality, and operational requirements, contributing to the delivery of safe and compliant manufacturing operations.
Job Responsibilities
Develop and execute validation deliverables including validation plans, risk assessments, protocols (IQ/OQ/PQ), and summary reports for GxP systems.
Support the qualification and validation of systems such as MES, automation platforms, LIMS, and other manufacturing and quality systems.
Ensure alignment with data integrity, GMP, and GAMP 5 standards across all validation activities.
Collaborate with system owners, QA, and IT to maintain validated status and support change control, deviations, and CAPAs.
Perform periodic reviews and impact assessments to ensure continued compliance and system reliability.
Participate in audits and inspections, providing documentation and technical expertise as required.
Contribute to continuous improvement initiatives within the site's validation and quality assurance programs.
Job Requirements
Bachelor's degree in Engineering, Computer Science, or a related discipline.
Minimum 5 years of CSV experience within a GMP-regulated pharmaceutical or biotech environment.
Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance frameworks.
Experience validating MES, automation, and/or laboratory systems highly desirable.
Excellent technical writing, communication, and organizational skills.
Proven ability to manage multiple validation projects in a fast-paced manufacturing environment.
Ability to work on-site in Killorglin, Kerry as part of a collaborative, cross-functional team.